PHARMACOVIGILANCE & DRUG SAFETY SUMMIT FORUM

Conference overview

The stringent regulations on safety monitoring increased the safety in data collection, analysis and regulatory surveillance. Adding to this the rising demand for drugs, the amplified need for novel therapeutics development via extensive clinical trials and the world population growth made drug manufacturers start paying more attention to Pharmacovigilance as public anxiety about safety increases.

Furthermore, the growth of exponential rare and chronic diseases contributed to an increased need for drug development, therefore this led the industry to have a bigger focus on drug safety.

On this B2B event, participants will have the chance to learn more about this challenging era and the latest developments in Pharmacovigilance and Drug Safety with the main key players in this field.

This event will be focusing on trends on Regulatory challenges, Signal detection, Data management, Risk management, Audit & Inspection and New technology applied to Pharmacovigilance procedures.

We invite you to discuss and debate these challenges in a dialogue amongst top professionals in Pharmacovigilance.

Key Topics

– Using Real-Word data from social media and other sources for signal detection
– Managing diverse data sets and applying advanced analytical and statistical modelling techniques
– Cloud-Based reporting to bring a robust global database of ADRs
– Automation of adverse events reporting and artificial intelligence application
– Applying data analytics in Pharmacovigilance processes to increase the speed of signal detection
– Making sure your operations are aligned with the FDA’s current thinking on data integrity
– QPPV Update: EudraVigilance (EV) – The new EV System
– EMA’s WEB-RADR and the FDA’s sentinel initiative
– Impact of personalized medicine on pharmacovigilance
– Outsourcing to increase efficiency and cut your costs – The benefits and challenges
– Artificial intelligence to turn PVO into a predictive science
– Comply with FDA’s June 2018 deadline for combination product safety reporting
– Being ready for an inspection of your pharmacovigilance system
– Benefit-Risk Evaluations: The patient perspective
– Overcoming the timeline challenges in communicating rapidly with Market Authorisation Holders
– Implementing global harmonization practices in the areas of drug safety and risk management
– Minimizing ADRs by including the patient as one pillar of the therapeutic plan

- Important issues for a successful Risk Management Plan (RMP)
- The RMP as a valuable tool to improve safety profile of high risk products
- The effective communication/implementation of risk minimization measures. Role of Pharma companies and Regulators

- Vision of Pharmacovigilance (PV) in 21st century
- What is Personalised Medicine - Do we know what it does exactly mean?
- More targeted therapy less adverse event - Is it true?
- More targeted therapy less adverse event - Is it true?
- Role of PV experts in the rapidly changing environment - Positioning our role in in the old set-up for future goals

13:50 Case Study | Outsourcing of Pharmacovigilance activities: how to select and monitor the performance of third parties

- Identify the activities mainly outsourced
- Analyze the criteria to be taken into consideration for the selection of a "Service Provider or vendor"
- Monitor its performance (KPI) and the quality of services
- Evaluate analytically and strategically when outsourcing a service and when to keep it in-house